Baclofen
- Product NDC
- 0615-8518
- 11-digit product format
- 006158518
- Labeler code
- 0615
- Product ID
- 0615-8518_8c1dfdbe-e30f-436d-882e-8b4c5f8ca29a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA215885
- Marketing category
- ANDA
- Marketing start
- 2022-01-26
- Substance
- BACLOFEN
- Active strength
- 5 mg/1
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| H789N3FKE8 | BACLOFEN | 1134-47-0 | BACLOFEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8518-05 | 00615851805 | 15 TABLET in 1 BLISTER PACK (0615-8518-05) | 15 tablet | 2024-08-14 | No | No | Historical |
| 0615-8518-39 | 00615851839 | 30 TABLET in 1 BLISTER PACK (0615-8518-39) | 30 tablet | 2024-08-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Baclofen Tablets, USP Rx only | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-10-04 | HUMAN PRESCRIPTION DRUG LABEL | 2 |